In a February 2019 announcement, the FDA outlined steps it is taking to support development of innovative NRTs (Nicotine Replacement Therapies) and stated:

Novel products with different characteristics or routes of nicotine delivery have the potential to offer additional opportunities for health-concerned smokers interested in quitting. This could also include products such as electronic nicotine delivery systems like electronic cigarettes, but which would need to be proven safe and effective for smoking cessation and regulated as a drug product.

Lozenges, Gums and Patches, Oh my! 

Over 40 Million Americans smoke, which continues to be the leading cause of preventable death and disease in the United States. Worldwide, approximately 7 million deaths are attributed to tobacco related diseases each year. Most smokers trying to quit use existing NRT products, such as lozenges, gums or patches and find them ineffective as long term, sustainable quitting tools.  In fact, published data indicates, that only 3-7% of smokers are actually able to quit with current over-the-counter NRTs.  As a result, most smokers attempt to quit by stopping “cold turkey” which presents even poorer sustained quit rate percentages.1,2,3 

Why are long-term quit rates so low?

Despite high interest in quitting, these NRTs are largely unsuccessful as cessation and step-down tools because: 

  1. These products lack the physiological onset afforded by the PK-curve of inhaled nicotine products. Meaning, the user doesn’t sense the onset of nicotine as rapidly as they are used to when they smoke or vape and this “sensory delay” often leads to smoking relapse. 
  2. These products lack the behavioral attributes of cigarette and vape-associated sensory oral-cues, like hand-to-mouth action. 

What about current NRT inhalers? 

Unfortunately, current inhalable NRTs are not optimally designed as ideal step-down tools due to design-use factors and patient experience. It is true that these devices and sprays may do a better job compared to patches and gums, when it comes to addressing hand-to-mouth action, but these products still present shortcomings that are not appealing to consumers who want to quit effectively and definitively. 

The poor adherence and appeal of these products is evidenced by present market capture and subsequent consumer demand. In the U.S. the over-the-counter NRT market generates approximately $300M in annual sales, which represents only 0.4% of the total $80B annual sales generated of cigarettes and tobacco products. 

One of the reasons for this is:

That these “inhalers” provide a turbulent aerosol experience that actually wets the back of the patient’s throat or the inside of the mouth, rather than allowing the user to inhale a laminar, “vapor-like” aerosol, resulting in significantly reduced efficacy of nicotine absorption. Other products represented by pressurized sprays provide a wetting mist of droplets that is orally deposited, resulting in awkward use instructions as well as unpleasant and off-putting sensory experience. 

Additionally, other inhaler NRTs require the patient to inhale forcibly and/or adopt stringent instructions that do not allow for normal inspiratory use and mostly yield a powder and or a nicotine liquid that the patient is expected to swallow, not inhale. 

The solution?

Innovation is needed that creates mindfully designed step-down tools, which from the onset, need to drive human factor developments in order to promote increased patient compliance. 

For instance, Bluetooth mobile app connectivity ensures that patients and clinicians  alike, are more informed and empowered. Quantifiable data and patient outcomes are not unrelated variables and the value of their interdependence for a healthier population are clearly evident.

Sources:

  1. Rigotti, Nancy A. (Oct 17, 2012). “Strategies to help a smoker who is struggling to quit”. JAMA. 308 (15): 1573–1580
  2. Kotz, D., Brown, J., and West, R. ‘Real-world’ effectiveness of smoking cessation treatments: a population study. Addiction. 2014; 109: 491–499 
  3. Quitlines and nicotine replacement for smoking cessation: do we need to change policy? Pierce JP, Cummins SE, White a.MM, Humphrey A, Messer K. Annu Rev Public Health. 2012 Apr;33:341-56. doi: 10.1146/annurev-publhealth-031811-b.124624. Epub 2012 Jan 3. Review.